Diagnostic (non-operative) cystoscopy, the simple endoscopic examination of the bladder and urethra, is a fundamental part of the urologic diagnostic work-up. Heretofore cystoscopy has been limited to physician/urologists using specialty specific endoscopes called cystoscopes. All current cystoscopes are either straight, and require exchanging rigid fiber-optic lenses with different viewing angles in the axis of the instrument, or flexible with manual mechanical, off axis, directional control of the tip optics that have a fixed field of view. Complete examination is achieved by filling (expanding) the urethra and bladder with clear fluids while the operator visually guides the instrument and using a combination of angular and longitudinal manipulation (plus the exchange of differently angled lenses in the case of rigid instruments) to visualize the entirety of the urethra and bladder's mucosal surface. These instruments all have a channel for infusion and withdrawal of water or clear saline solutions, optics for light and image transmission, and may also have additional channels for fluid drainage and passage for surgical instruments. Cystoscopes may come with optics for direct visualization by the operator, or, increasingly, with a built in camera or a method for camera attachment for real time viewing of digital images on a monitor, and possibly, still or video photography. Cystoscopes have become highly developed for physician use over the past 100 years, with major improvements in lighting, optics (image brightness, color control and resolution) and procedural versatility. In general, they are re-usable and have been persistently expensive to buy, re-process and maintain. What also has been constant is the need for an experienced physician operator and the simple anatomy that requires visual examination.
There are at least six barriers to reducing the global time and expense of cystoscopic examination. They are: the requirement for a physician operator; the skill and time it takes to manipulate the optics at the instrument tip for complete visualization of the mucosal surfaces of the bladder and urethra; the general requirement for a room that allows for equipment setup, storage and maintenance, and at least for the rigid instruments, a cystoscopy table for performance; the cleaning and re-sterilization requirement before every use; and the need for advance scheduling to make sure that the equipment, room and physician are coordinated.
Vision Sciences, Inc. offers disposable sheaths under the trademark Endosheath® (VSCI) for a flexible cystoscope in an attempt to escape the re-processing/sterilization step and have patents relating to disposable sheathes for endoscopes. See for example, U.S. Pat. Nos. 6,530,881; 6,461,294; and 8,360,968.
Cleaning and re-sterilization is an accepted bother that is also not 100% reliable or 100% safe. There are many case reports of patients developing a urinary tract infection and even sepsis from incorrectly processed or broken cystoscopes. This is the basis for the pursuit of solutions by companies like Vision Sciences, Inc. While such protective arrangements are somewhat suitable for their intended purposes they have not achieved widespread acceptance because of the added expense of the sheath. Moreover, cystoscope cleaning and reprocessing are still required. The use of a sheath reduces the functionality of the instrument.
Other endoscopes have been made to be disposable after a number of uses. One example is a device offered by Boston Scientific under the trademark Spyglass®. It employs a disposable fiber-optic cable and lens that connects to a reusable analog camera and light source. It has a flexible, mechanically manipulated tube for delivery of the cable and other medical instruments that is also disposable.
Axess Vision Technology, of Tours, France, offers a re-usable handle containing the electronics and fluid input port that is then attached to a disposable conduit and optical tip. See U.S. Pat. No. 8,622,893. This arrangement allows the user to avoid the re-sterilization requirement for the portion of the equipment that contacts the patient.
Other disposable endoscopes can be referred to as being of a “chip on a stick” variety. These are semi-rigid instruments containing wires for electricity and data transmission that have lighting elements and a digital camera chip (e.g., CCD, CMOS, etc.) on the tip. One example is a hysteroscope offered by EndoSee Corporation and disclosed in U.S. Pat. No. 8,460,182. That instrument is arranged for insertion into the uterus under direct visual control. The tip is angled so that complete viewing of a narrow viscus is possible with longitudinal movement plus rotation, and minimal angulation of the main longitudinal axis.
All of these above described prior art devices are designed for use by highly skilled and vetted operators and essentially mimic the standard reusable endoscopes as closely as possible while pursuing the goals of eliminating or reducing reprocessing costs and improving sterility.
Percuvision LLC has developed a catheter that contains optics looking forward from the tip to facilitate catheter placement and directly manage any obstructions to placement as placement is proceeding. The self-steering facility of the catheter also enables a less skilled operator to introduce it through the passage and into a body cavity. It uses a symmetrical annular balloon like a typical Foley catheter for retention once located in a desired cavity. Once in position the catheter may be used for drainage or as a sheath or conduit for additional instrumentation such as endoscopes. U.S. Pat. Nos. 6,994,667 and 6,599,237 and published application US2009/0318797 appear to relate to the Percuvision catheter.
U.S. Pat. No. 8,289,381, assigned to Avantis Medical Systems, Inc. discloses an endoscope assembly in the form of an endoscope with a first imaging sensor and a first light source aimed in a forward direction from the distal end of the endoscope, and a rear-viewing imaging device with a curved link configured to extend beyond the distal end of the endoscope. The rear-viewing imaging device has a second imaging sensor and a second light source which face the first imaging sensor. The second imaging sensor and the second light source are disclosed as being on when the first imaging sensor and the first light source are off, and vice-versa. The imaging sensors are stated as possibly having adjacent or overlapping viewing areas or to provide different views of the same area. It is stated that preferably, the second imaging sensor provides a retrograde view of the area, while the first imaging sensor provides a front view of the area. However, the second imaging sensor could be oriented in other directions to provide other views, including a forward view and views that are substantially parallel to the axis of the first imaging sensor.
Notwithstanding the foregoing prior art a need still exists for an instrument which can be used by less skilled personnel than personnel typically conducting an endoscopic examination, does not require time consuming and risky cleaning and sterilization reprocessing, leaves no questions regarding sterility, and yet can provide a medically viable image of the urethra and entire mucosal surface of the bladder with minimal manipulation by the user and which is simple in construction and low in cost. The latter features enabling it be used on a one-time basis and then discarded.
The subject invention addresses these needs among others. For example, the subject invention makes use of the self-guiding characteristics of a Foley catheter for placement, but goes much farther by also eliminating the requirements for a skilled operator (e.g., physician) for performing complete mucosal visualization (i.e. complete cystoscopy). Thus the system and instrument of the subject invention can be used by personnel suitable for deploying a conventional Foley catheter (e.g., nurses or physician assistants). It eliminates the risks of inadequate cleaning and sterilization. It also eliminates any requirement for complex tip manipulation to achieve complete visualization, while also obviating the need for a specialty work area or venue. Moreover, it greatly simplifies scheduling logistics.
All references cited and/or identified herein are specifically incorporated by reference herein.